Kornimate/medical-research-clean huggingface dataset:
effects of functional electrical stimulation in patients undergoing coronary artery bypass grafting surgery

Conditions: Muscle Wasting

Summary: even with major advances in clinical therapy and percutaneous interventions, coronary artery bypass grafting (cabg) is the most common cardiac surgery performed worldwide and is an effective treatment in reducing symptoms and mortality in patients with coronary artery disease (cad). however, cabg is a complex procedure that triggers a series of clinical and functional complications, such as series postoperative repercussions as muscle wasting in the first four hours after surgery. for quantification of changes in muscle structure and morphology ultrasonography has been used. in this context, cardiac rehabilitation program (crp) is an essential component of care in cabg patients, because this intervention can prevent muscle weakness and wasting. among different treatment modalities, functional electrical stimulation (fes) is a feasible therapy for neuromuscular activation and prevent muscle weakness and wasting in patients in phase i crp, however the effect of this intervention in phase ii crp not been fully elucidated. the purpose of this study will to assess the effects of fes plus combined aerobic and resistance training on muscle thickness of quadriceps femoris, lower limbs muscle strength, functional capacity, qol in in cabg patients enrolled in a phase ii cr program.


Eligibility criteria:
inclusion criteria: patients undergoing cabg up to three weeks before the initiation of the study, a clinical course without complications during hospitalization * clinically stable * the absence of smoking (previous or current). exclusion criteria: * unstable angina * myocardial infarction and heart surgery up to three months before the survey * chronic respiratory diseases * hemodynamic instability * orthopedic and neurological diseases that may preclude the achievement of the cardiopulmonary test and cardiac rehabilitation exercises * psychological and/or cognitive impairment that restrict them to respond to questionnaires * changes of skin sensitivity,skin lesion and allergic skin problems * severe lymphedema * uncontrolled diabetes mellitus * acute superficial venous thrombophlebitis * systemic arterial hypertension
sy007 in patients with acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: this phase 1b multiple center, randomized, double-blind, placebo-controlled study is a dose escalation trial evaluating the safety, tolerability, pk characteristics and efficacy of sy-007 after injection in acute ischemicstroke patients. the immunogenicity of sy-007 will be evaluated and this study will provide the recommended dosage for subsequent clinical trials.


Eligibility criteria:
key inclusion criteria: * aged from18 years to 80 years * within 24h after the onset of stroke symptoms (time the patient was last seen well) * score range from 4 to 20 points, inclusive, on the nihss at randomization * prior to index stroke, patient was able to perform basic activities of daily living without assistance, mrs score≤1 * absence of intracranial hemorrhage on brain ct or mri * patients or legal representatives can give informed consent key exclusion criteria: * venous thrombolytic therapy or endovascular treatments have been applied for patients; or patients plan to conduct these kind of treatments. * glasgow score of patients ≤8 * patients are receiving oral anticoagulants or inr\>3.0 * baseline blood platelet counts \<80\*109/l * nihss score could not been obtained at baseline * fpg levels \ 400mg/dl * patients with kidney disorder egfr \<30 ml/min or patients need dialysis * patients with acute and chronic hepatitis, or liver diseases (ast or/and alt \>2 × uln(upper limit normal)) * systolic blood pressure≥220mmhg or/and diastolic blood pressure≥120mmhg ; or blood pressure under 90/60mmhg.
a pharmacokinetic/pharmacodynamic inhaler comparison study in healthy volunteers

Conditions: Asthma

Summary: a 2-group healthy volunteer study to compare a breath actuated inhaler (bai) and a pressurised metered dose inhaler (pmdi) with and without spacer.

group 1 will assess pharmacokinetics, group 2 will assess pharmacodynamics. pk interim analysis to determine requirement for pk extension. group 1 (pk) blood sampling and safety assessments up to 36 hours post-dose for 3 study periods. results from pk stage will determine if group 2 (pd) is required. group 2 (pd) will assess laba only effects (as confirmed in interim analysis). group 2 (pd) to include 2 overnight stays for 5 study periods. volunteers will receive a single dose of study medication, with discharge on day 2. study treatments are fluticasone/formoterol bai, fluticasone/formoterol pmdi with/without spacer, formoterol alone without spacer, and low dose fluticasone/formoterol without spacer. volunteers will undergo blood sampling, and safety assessments up to the morning of discharge. an inspiratory flow recorder (ipr) will be used for training and to monitor inspiratory flow rate, inhaled volume and inhalation technique.

Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 years or over. * healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ecg. * normal lung function (fev1 \>90% of predicted normal value). * demonstrate satisfactory technique in the use of the study drug devices. * no use of steroid medication (systemic or topical) within 8 weeks prior to study screening. exclusion criteria: * subjects who use any asthma medication or are knowingly regularly exposed to asthma medication. * any history of drug or alcohol abuse. * any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion. * history of asthma, copd, or other bronchial or lung diseases. * user of steroid medication (systemic or topical) within 8 weeks prior to study screening.
chinese medicinal herbs treatment on novel influenza a (h1n1)pneumonia: multi-centre, prospective, randomized controlled study

Conditions: Influenza

Summary: the purpose of the study is to determine whether the combination treatment of chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza a (h1n1) pneumonia.

the antiviral agent, oseltamivir, is recommended by the world health organization (who) to treat recent outbreak novel influenza a (h1n1) virus infection around world. but limited stock and resistant strain emergence raised increasing concerns. chinese medicinal herbs, are derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat the disease. the investigators performed rct to indicate that a combination treatment of chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza a (h1n1) pneumonia.

Eligibility criteria:
inclusion criteria: * confirmed novel influenza a(h1n1) case with laboratory evidence * 70 ys ≥ age ≥14ys * within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom) * new lung infiltration showed by chest radiology(x-ray or ct) exclusion criteria: * age\ 70ys * pregnancy * severe chronic underlying diseases: severe copd(fev1/evc \ 2mg/dl), chronic heart failure(nyha ⅲ-ⅳ grade） * immunocompromised patients(cancer, organ transplant, aids and a history of treatment with immunosuppressive drug and glucocorticoids in the past 3 months) * taken chinese medicinal herbs, antiviral or antibiotic drug in the past 2 weeks * inoculation influenza vaccination * one of the following items appeared at the enrollment * respiratory failure：pao2\ 50mmhg or pao2/fio2≤300 * circulation failure: despite adequate fluid resuscitation and cardiac output, systolic \<90mmhg or requirement inotropic support * renal function failure: despite adequate fluid resuscitation and cardiac output, urine ≤ 0.5ml/kg.h, cr or bun≥1 time normal elevation * liver function failure: total bilirubin\>34μmol/l or alt/ast ≥3 times normal elevation * other unappropriated enrollment situations considered by investigator

Keywords: novel influenza a(h1n1) chinese medicinal herbs
sensory synchronized imaging and neuromodulation

Conditions: Major Depressive Disorder

Summary: the purpose of this research study is to better understand the relationship between the type of brain stimulation used and how it changes brain activity in adult military veterans. the goal is to use this understanding to develop new, personalized brain stimulation. the investigators evaluate brain changes from different types of transcranial magnetic brain stimulation (tms).


Eligibility criteria:
inclusion criteria: * men and women, ages 18 years and up * english speaking * military veterans exclusion criteria: * those with a contraindication for mris (e.g. implanted metal) * history of head trauma with loss of consciousness * history of seizures or on medications that substantially reduce seizure threshold * neurological or uncontrolled medical disease * active substance abuse * currently pregnant or breastfeeding
observational study of comparison effectivity between remdesivir and favipiravir in surabaya, indonesia

Conditions: Duration of Hospitalization; Clinical Manifestation of COVID-19

Summary: in order to compare the effectiveness between remdesivir and favipiravir, an observational analytic study using a retrospective cohort design. eighty-eight medical records of covid-19 patients from january to august 2021

coronavirus disease 2019 (covid-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (sars cov-2). antiviral therapies are considered to be one of the covid-19 treatments. remdesivir and favipiravir are the antivirals recommended by indonesia's 3rd covid-19 management guidelines. they have a similar mechanism to inhibit virus replication, specifically by inhibiting rna-dependent rna polymerase (rdrp) of the virus. several studies reported that patients who received these antivirals had a lower duration of hospitalization. however, the effectiveness comparison of remdesivir and favipiravir remains unknown. an observational analytic study using a retrospective cohort design. eighty-eight medical records of covid-19 patients from january to august 2021 are collected by consecutive sampling technique, and this research was carried out at gotong royong hospital surabaya.

Eligibility criteria:
inclusion criteria: * adult patients (eighteen years old or above) with moderate to severe covid-19 (categorized based on keputusan menteri kesehatan republik indonesia nomor hk. 01. 07/menkes/413/2020); * admitted to gotong royong hospital surabaya from january 2021 to august 2021; * received remdesivir or favipiravir with minimal five days of treatment * not in pregnancy and lactating condition exclusion criteria: * female patient with pregnancy and lactation * patient whom was passed away or forced home during two-weeks observation period
finnish vitamin d trial (find)

Conditions: Cardiovascular Diseases; Cancer

Summary: the finnish vitamin d trial (find) is a randomized, double-blind, placebo-controlled, 5-year supplementation study of the benefits and risks of vitamin d in the primary prevention of cardiovascular (cvd) and cancer among 18000 men 60 years or older and women 65 years or older. \[edit 25.3.2015: due to difficulties in recruitment and funding, the study size is approximately 2500 subjects, with a 550 subject subgroup with more detailed examinations\] the participants will be randomized to 3 groups with 6000 in each, with daily supplementation of either: 1) 40 µg/day (1600 iu) of vitamin d3, 2) 80 µg/day (3200 iu) of vitamin d3, or 3) placebo. \[edit 15.3.2015: the 2500 subjects are randomized in 3 groups, approximately 830 subjects per group.\] compliance, use of non-study drugs or supplements, diet, development of endpoints, and cvd and cancer risk factors will be assessed by questionnaires. blood samples will be collected for assessment of effect modification by baseline 25-hydroxyvitamin d, as well as for future ancillary studies of genetic/biochemical hypotheses. event data will be obtained by record linkage from the national computerized hospitalization registry.

more detailed description available upon request.

Eligibility criteria:
inclusion criteria: * men 60 years or older * women 65 years or older exclusion criteria: * cardiovascular disease (including myocardial infarction, stroke, transient ischemic attack, angina pectoris, coronary artery bypass grafting, or percutaneous coronary intervention). * cancer (except non-melanoma skin cancer). * any disease or state that raises a vitamin d related safety concern (such as chronic liver, thyroid or kidney disease, hypercalcemia, sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or wegener's granulomatosis). * use of supplements yielding vitamin d over 20 µg/day or calcium over 1200 mg/day and unwillingness to discontinue the use.

Keywords: bone density conservation agents cancer cardiovascular disease cholecalciferol diabetes mellitus, type 2 dietary supplements primary prevention vitamin d
a study of mabthera (rituximab) in patients with advanced non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this 2 arm study will compare the efficacy and safety of the standard chemotherapy of the east german study group for hematology and oncology versus standard chemotherapy plus mabthera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-hodgkin's and mantle cell lymphoma. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * advanced, low-grade non-hodgkin's and mantle cell lymphoma. exclusion criteria: * possibility of curative radiation therapy; * secondary nhl; * participation in another clinical trial eg with cytostatic chemotherapy or cytokines; * concomitant diseases and/or restricted organ function precluding therapy according to the study protocol.
prospective observational study on the management of patients with relapsed or refractory follicular lymphoma (olympe)

Conditions: Follicular Lymphoma

Summary: this french national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of mabthera® (rituximab) maintenance therapy. actively participating physicians will enroll patients and collect therapeutic management data in a real-life setting up to 5 years.


Eligibility criteria:
inclusion criteria: * adult patient (age \>/= 18 years) * presenting with who grade 1-3, cd20-positive follicular non-hodgkin's lymphoma, histologically confirmed at initial diagnosis * in relapse (or refractory) after at least one line of treatment, regardless of the nature of previous treatments (chemotherapy and/or immunotherapy and/or radioimmunoconjugate therapy and/or radiation+chemotherapy) and for whom a decision was made to give salvage therapy * having received oral and written information about the study and having raised no objections to electronic capture and processing of his/her personal data exclusion criteria: * patient participating in a clinical trial evaluating a new, non-commercialized cancer treatment at the time of inclusion * follicular lymphoma presenting with a transformation to diffuse large cell non-hodgkin's lymphoma * first line treatment with radiotherapy alone * initial abstention from treatment (decision to not treat the progression at the time of inclusion in the olympe study)
effect of intercostal nerve block with ropivacaine combined with mecobalamine on chronic pain after thoracic surgery

Conditions: Postoperative Pain

Summary: this project intends to investigate the effects of intercostal nerve block with ropivacaine combined with mecobalamin on chronic post-surgical pain (cpsp) in thoracic postoperative patients. related clinical characteristics of postoperative chronic pain. the results of the study provide clinicians with a simple and inexpensive new method of preventing cpsp, in order to prevent the occurrence of cpsp and reduce the incidence of cpsp, thereby reducing cpsp to patients and their families, hospitals. and public resources.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, conscious; 2. asa class ⅰ \~ ⅲ; 3. thoracoscopic lobectomy was proposed; 4. the han nationality; 5. native speaker of chinese; 6. agree to participate in this study and sign the informed consent. exclusion criteria: 1. patients allergic to meccobalamin or ropivacaine; 2. patients with previous history of chest surgery; 3. patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture; 4. patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease; 5. diabetic patients; 6. patients who need other drugs for pain relief but have not completed treatment or have completed treatment.
brain's response to chocolate

Conditions: Overweight; Obesity

Summary: the purpose of this study is to test how the brain responds when individuals eat enjoyable foods such as chocolate. eating certain foods can make one want to keep eating even when feeling full, caused by dopamine in the brain. the researchers believe this dopamine response can be measured by looking at the individual's eye.

with obesity at an all-time high, understanding eating behavior beyond physical need is a priority. food reinforcement is driven by central dopamine activity. however, objective measurement of brain dopamine-related behavioral events is hindered by the lack of non-invasive, accessible techniques that are amenable to testing in a "naturalistic" environment. the goal of this project is to develop a non-invasive, accessible methodology to measure dopaminergic responses to food in a natural setting. this research will use a novel, hand-held electroretinograph (erg) that does not require eye dilation and uses a skin electrode to measure retinal dopamine activity. previous work establishes that retinal dopamine activity can be used as a proxy for central dopamine function. the ability to assess both subjective behavioral variables and central dopaminergic responses simultaneously will provide an ideal approach for innovative studies of the control of eating behavior.

Eligibility criteria:
inclusion criteria: * body mass index 20-30 kg/m2 * free of any major illness or disease exclusion criteria: * food allergies * participation in a weight loss diet or exercise program * pregnancy * lactation * metabolic illness or disease (diabetes, renal failure, thyroid illness, hypertension) * eye illness or disease (narrow angle glaucoma, macular degeneration, retinal detachment, cataracts) * psychiatric, neurological or eating disorders (schizophrenia, depression, parkinson's disease, huntington's disease, cerebral palsy, stroke, epilepsy, anorexia nervosa or bulimia nervosa) * take prescription medications except for oral contraceptives or antihyperlipidemia agents
motion delos: an open label safety and efficacy of tradipitant in participants affected by motion sickness

Conditions: Motion Sickness

Summary: an open label study to investigate the safety and efficacy of tradipitant in participants affected by motion sickness during travel

this is an open label study to investigate the efficacy and safety of tradipitant in motion sickness affected male and female participants during events historically known to cause motion sickness.

Eligibility criteria:
inclusion criteria: * history of motion sickness * age 18-75 exclusion criteria: * nausea-inducing disorder other than motion sickness * bmi \> 40 * history of intolerance and/or hypersensitivity to neurokinin-1 receptor antagonists
evaluate the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice or three times daily in patients with acute ankle sprain

Conditions: Grade I/II Ankle Sprain

Summary: the main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).


Eligibility criteria:
inclusion criteria: 1. acute sprain of the lateral ankle, grade i-ii . exclusion criteria: 1. any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient. 2. topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.

Keywords: ankle sprain soft tissue injury
legion™ revision metal hypersensitivity study

Conditions: Total Knee Replacement Revision

Summary: this is a prospective, randomized, multi-center, metal hypersensitivity study comparing oxinium and cobalt chrome femoral components in subjects with failed total knee arthroplasty (tka).

a total of 230 subjects will be randomized (1:1) to receive either an oxinium or cobalt chrome femoral components as part of their legion revision procedure. the objective of this study is to assess a lower serum metal ion concentration level in at least one of the three major mltts (co, cr or ni) over 5 years in subjects receiving oxinium versus cobalt chrome femoral components as part of the legion revision total knee system.

Eligibility criteria:
inclusion criteria: * subject is skeletally mature * subject is willing to sign and date an irb/ec approved consent form * subject is a candidate for a revision knee replacement * subject has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk * subject agrees to adhere to the 10-year study visit schedule exclusion criteria: * subject with a known metal hypersensitivity * subject requires a known bilateral revision tka * subject has severe pronation of the ipsilateral foot or any other relevant clinical condition contributing to abnormal ambulation * subject has active infection or sepsis (treated or untreated) * subject with an immunosuppressive disorder * subject has presence of malignant tumor, metastatic, or neoplastic disease * subject has conditions that may interfere with the tka survival or outcome (i.e., paget's or charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease) * subject has had intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment * subject has inadequate bone stock to support the device and would require significant augmentation to correct the joint female subject is of child-bearing age and unwilling to use an approved method of contraception * subject has an emotional or neurological condition that would pre-empt their ability or willingness to comply with the study * subject is severely overweight (bmi\>40) * subject is currently enrolled in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days * subject is facing current or impending incarceration

Keywords: hypersensitivity metal sensitivity arthroplasty implant-related hypersensitivity metal-on-metal implants knee revision